Kornimate/medical-research-clean huggingface dataset:
multicenter study of safety and efficacy of prolgolimab in patients with advanced melanoma in routine clinical practice

Conditions: Advanced Melanoma

Summary: describe the safety, tolerability, efficacy and approaches to prescribing prolgolimab in the standard dosing regimen of 1 mg / kg every 2 weeks in patients with advanced melanoma in routine practice. prolgolimab (forteca, formerly bcd 100) is an igg1 anti-pd-1 (programmed cell death protein 1) monoclonal antibody containing the fc-silencing 'lala' mutation.

describe the safety and tolerability of using prolgolimab at a standard dosage regimen of 1 mg / kg every 2 weeks. describe the efficacy of prolgolimab 1 mg / kg every 2 weeks in patients with metastatic or inoperable melanoma in routine practice, based on the following indicators: progression-free survival (time from first dose of prolgolimab to disease progression or death for any reason); overall survival (time from receiving the first dose of prolgolimab to death for any reason); objective response rate (proportion of patients with a complete or partial response to prolgolimab therapy).

Eligibility criteria:
inclusion criteria: histological confirmed melanoma advanced stage (unresectable iii or metastatic iv) treated by at least one therapy line including prolgolimab in routine practice - exclusion criteria: - patient participation in any interventional clinical study.
oxytocin dosing at planned cesarean section and anemia

Conditions: Blood Loss Anemia; Uterine Atony With Hemorrhage

Summary: patient's with planned cesarean sections will be randomized to receive either standard 20 mu in 1l as a bolus following delivery of the placenta or 20 mu in 1l following delivery of the placenta plus an additional 20 mu in 1l over 8 hours.

the purpose of this study is to examine the impact of differential dose protocols commonly utilized in the post cesarean period to determine if laboratory definitions of anemia are different. oxytocin is an antidiuretic hormone that is utilized after delivery of the fetus and placenta to contract the uterus and decrease blood loss both at the time of surgery and in the post-partum period. here at the penn state hershey medical center the investigators will use 20 units of oxytocin in a 1 l bag of lr in bolus fashion after delivery of the placenta. other protocols use an extended course of therapy using 20 units of oxytocin in a 1 l bag of lr in a bolus plus an additional 20 units of oxytocin in a 1 l bag of lr over an 8 hour period of time. we hypothesize that: * women who receive the standard 20 mu of oxytocin in 1l of lr in bolus fashion plus 20 mu in 1l over 8 hours will have a decreased reduction in pre-operative vs post-operative hematocrit and hemoglobin versus those that receive 20 mu in 1l of lr. * women who receive the standard 20 mu of oxytocin in 1l of lr in bolus fashion plus 20 mu in 1l over 8 hours will have decreased blood loss by weight in the postpartum period compared to patients who receive 20 mu in 1l of lr.

Eligibility criteria:
inclusion criteria: * planned cesarean sections for singletons at or greater than 37 weeks gestational age * primary or repeat cesarean section will be included exclusion criteria: * multiple fetal pregnancies * hematologic disorders * fetal anomalies * pre-eclampsia. these patients are at increased risk of fluid overload and so fluid status may be affected by receiving a second bag of fluid containing oxytocin in the postpartum period. * known contraindication to oxytocin * hypersensitivity to oxytocin * patients who have labored and then proceed with cesarean section for any reason. patients who have labored have had either intrinsic or extrinsic exposure to oxytocin. these patients may have decreased sensitivity to oxytocin.
a study of different types of fatty acid on risk factors for heart disease

Conditions: Cardiovascular Risk Factors

Summary: experimental elevation of non-esterified fatty acids (nefa) impairs endothelial function and insulin sensitivity but the impact of nefa composition is unknown. the objective was to test the effect of acute elevation of nefa enriched with either saturated fatty acids (sfa) or sfa with long-chain n-3 polyunsaturated fatty acids (lc n-3 pufa) on postprandial vascular function measured via flow-mediated dilatation (fmd), laser doppler iontophoresis (ldi) and digital volume pulse (dvp), followed by a hyperinsulinaemic-euglycaemic clamp as a measure of whole body insulin sensitivity.

to investigate potential diet-gene interactions, potential subjects (n=370) were prospectively genotyped for the enos glu298asp polymorphism, of which 35 were asp298 and 150 were glu298 homozygotes. three subjects in the asp298 group were unable to participate, two were unsuitable according to selection criteria and one subject subsequently withdrew from the study. subjects homozygous for asp298 (n=29) and glu298 (n=30) were therefore selected, balanced for gender, age and bmi.

Eligibility criteria:
inclusion criteria: * healthy * either homozygous for enos glu298 (wildtype)or enos asp298 (variant) exclusion criteria: * smokers * raised fasting blood lipids * taking excessive fish oil supplements (\>1g epa/dha per day) * taking medication known to influence blood lipids, blood pressure or blood clotting

Keywords: endothelial function non-esterified fatty acids insulin sensitivity
ease of use and blood clotting for the gambro polyflux hd-c4 big dialyzer

Conditions: Chronic Kidney Failure

Summary: the purpose of this study is to collect information on the ease of use and thrombogenicity of the polyflux hd-c4 big and fresenius optiflux 180nr or 200nr dialyzers under conditions of routine clinical use for hemodialysis.

this ease of use study involves the use of fda 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. this study is aimed at obtaining feedback from the nursing and technical staff regarding the use and thrombogenicity of the polyflux hd-c4 big, and fresenius optiflux 180nr or 200nr dialyzers. the dialysis nursing staff will complete ease of use and thrombogenicity assessments following routine dialysis therapy. any adverse events will be tracked for the study patients.

Eligibility criteria:
inclusion criteria: * hemodialysis patients 18 years of age or older exclusion criteria: * n/a

Keywords: dialyzer
pha-739358 for treatment of hormone refractory prostate cancer

Conditions: Metastatic Hormone Refractory Prostate Cancer

Summary: to assess the antitumor activity of pha-739358 administered as iv infusion according to two different dose schedules in metastatic hrpc patients progressing on standard, docetaxel-based 1st-line chemotherapy for hrpc based on psa response, and to select the best dose schedule for further investigation.


Eligibility criteria:
inclusion criteria: * metastatic hormone refractory prostate cancer progressing after docetaxel based therapy * adequate bone marrow, liver and kidney function exclusion criteria: * more than one prior chemotherapy line * uncontrolled hypertension * brain or leptomeningeal disease * myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months
the short-term efficacy of gastrodia and uncaria drink in treating hypertension

Conditions: Masked Hypertension

Summary: the purpose of this study is 1. to determine whether the gastrodia and uncaria drink is effective in the treatment of masked hypertensive patients below 70 years. 2. to find out the suitable groups for the gastrodia and uncaria drink treatment.


Eligibility criteria:
inclusion criteria: * age between 18 to 70 years * didn't use any anti-hypertension drugs within 2 weeks * stage 1 masked hypertensive patients, which means clinic blood pressure\<140/90 mmhg,however the daytime(8:00-18:00) 24h ambulatory blood pressure between 135/85 and 150/95mmhg * be willing to participate in the trials and able to finish clinic visit exclusion criteria: * secondary hypertension * be allergic to the clinical trial medicine * occurrence of stroke, ckd, myocardial infarction within 2 years * dysfunction of liver or kidney and fundus hemorrhage * arrhythmia * alt, ast, tbl upper the twice of normal range, scr≥2.0mg/dl, k+≥5.5mmol/l, urine protein≥2+ * psychiatric disorders * pregnant, breastfeeding * other serious conditions in which is not fit for the study

Keywords: clinical trials gastrodia and uncaria drink
stem cell transplantation for the treatment of knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to find if autologous stem cell transplantation can improve clinical manifestations of knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * moderate bilateral knee osteoarthritis exclusion criteria: * no infectious or inflammatory arthritis

Keywords: knee osteoarthritis
fetal cystoscopy versus vesico-amniotic shunting in severe lower urinary tract obstructions

Conditions: Lower Urinary Tract Obstructive Syndrome

Summary: there are two options of fetal treatment in cases of severe lower urinary tract obstructions: the vesico-amniotic shunting and fetal cystoscopy. there is no study confirming the effectiveness of these treatment, specially comparing both techniques. the present study aims to investigate the effectiveness of these treatments.

objectives: to evaluate the effectiveness of fetal cystoscopy for the diagnosis and therapy of the posterior urethral valves and to compare with the results of vesicoamniotic shunting. outcomes: accuracy of the prenatal cystoscopic diagnosis of posterior urethral valves, neonatal and infant survival (6 and 12 months), as well as normal renal function during the same ages. study design: randomized controlled trial. methods: pregnant women whose fetuses have isolated and severe lower urinary tract obstruction (luto) with (oligohydramnios and severe hydronephrosis) will be invited to participate in the present study. patients will be randomized into the fetal cystoscopic group (cysto) vs vesico-amniotic shunting (vas). the investigators intend to enroll 30 patients in each group (a total of 60). all patients will be followed by fetal ultrasound each 15 days. besides, these infants will be followed up to one year of age. maternal and obstetrical complications are going to be evaluated as well as neonatal and infant survival and the renal function.

Eligibility criteria:
inclusion criteria: * single pregnancy * male fetuses * gestational age dating by ultrasound examination performed before 20 weeks * confirmed severe luto (see details before) * severe oligohydramnios (afi\<5.0cm) * no other structural anomalies by complete fetal anatomy ultrasound scan and fetal echocardiogram * no abnormal karyotype * 'favorable' urine analysis (urinary sodium \ 20 weeks exclusion criteria: * presence of other anomalies diagnosed after fetal intervention * maternal refusal to participate in the present protocol

Keywords: luto posterior urethral valves urethral atresia
electrophysiological activity of the subthalamic nucleus during the processing of emotional and motivational information

Conditions: Parkinson

Summary: the role of the basal ganglia in the processing of information with emotional or motivational content has been demonstrated by several lesion and functional imaging studies in humans and animals. deep brain stimulation surgery provides an opportunity to study these structures in humans in electrophysiological terms. the aim of this study is to investigate modifications in the electrophysiological activity of the subthalamic nucleus (stn) during the perception of auditory and visual stimuli with emotional or motivational connotations in patients with parkinson's disease who have just undergone implantation of a deep brain stimulator in the stn.


Eligibility criteria:
inclusion criteria: * patient with parkinson's disease selected for deep brain stimulation (dbs) of the subthalamic nucleus (stn) in accordance with the criteria established by welter and colleagues (welter et al., 2002); * aged 18 years or above; * written informed consent from the patient. exclusion criteria: * patient under a legal incapacity or with limited legal capacity; * patient who has perioperative complications or postoperative confusion; * patient displaying cognitive disturbances involving the early stages of speech processing (on the basis of an audiogram systematically conducted prior to surgery) ; * patient displaying cognitive disturbances involving the early stages of face processing (on the basis of the benton facial recognition test (benton, hamsher, varney, \& spreen, 1983) systematically administered prior to surgery); * patient incapable of understanding the information given about the study, performing the tasks or providing informed consent.

Keywords: electrophysiology subthalamic nucleus parkinson
a placebo-controlled study assessing lateral branch radiofrequency denervation for sacroiliac (si) joint pain

Conditions: Low Back Pain

Summary: in order to determine whether l4 and l5 primary dorsal rami and s1-3 lateral branch radiofrequency denervation is effective for sacroiliac (si) joint pain, we are conducting a randomized, controlled study.

30 subjects with si joint pain confirmed by si joint injections will be randomized to receive either l4 and l5 primary dorsal rami and s1-3 lateral branch radiofrequency denervation or sham denervation. to facilitate patient blinding, in both groups 1 ml of lidocaine will be injected before true (or sham) denervation so patients cannot feel heating. the stimulation will be the same for both groups and blinding assessed after the procedure. follow-up visits will be at 1,3 and 6-months postprocedure.

Eligibility criteria:
inclusion criteria: * sacroiliac joint pain * age \> 18 exclusion criteria: * no focal neurological signs or symptoms, coagulopathy, unstable medical or psychiatric condition

Keywords: sacroiliac joint low back pain radiofrequency
effects of pursed lip breathing with and without mat pilates training in obese women

Conditions: Obese Women

Summary: obesity is defined as bmi more than or equal to 30kg/m2. it is responsible for manifestation of serious health problem. accumulation of adipose tissue in thorax and abdomen causes stiffness of chest, reduction in lung compliance and favoring airway closure. as result, reduction in lung volume and capacity occurs which requires increased breathing to maintain adequate oxygenation. these changes lead to limitations in activities of daily life. a randomized control study will be conduct to see the effects of pilates exercise and pursed lip breathing to improve the breathing and thoracoabdominal expansion. the study will be completed within 10 months after approval of synopsis. the sample size of 34 subjects will be taken: 17 with pilates method and 17 without pilates method with 12% attrition rate. pre assessment and post assessment will be made through ipaq questionnaire for physical activity measurement, borg's scale (cr-10) for dyspnea measurement and cirtometry for thoracoabdominal expansion. study will be conducted at star gym for women al-rehman garden community, lahore. data will be analyzed through spss 25.


Eligibility criteria:
inclusion criteria: * age(25-55 years) * female * dyspnea during intense exercise 0-10 * no experience of pilates exercise training * bmi \> 30 kg/m2 exclusion criteria: * smoking * pregnancy * practice of high intensity endurance training (squats, planks, lunges)

Keywords: borg's scale dyspnea ipaq mat pilates obese women thoracoabdominal expansion
antiretroviral treatment guided by proviral genotype: pilot trial of proof of concept.

Conditions: HIV-1-infection

Summary: phase iia, open clinical trial, pilot, single arm and proof of concept.

proof of concept trial evaluating safety and efficacy of treatment with dolutegravir (dtg) + lamivudine (3tc) once daily in suppressed participants with history of previous treatment with 3tc or emtricitabine (ftc). half of the participants will have history of failure with 3tc or ftc and m184v/i or k65r/e/n mutations in previous plasma genotypes, although to be eligible these mutations cannot be detectable at study entry in proviral dna.

Eligibility criteria:
inclusion criteria: 1. hiv-1 infected patients. 2. age\> 18 years. 3. receiving stable antiretroviral treatment for at least 3 months. 4. current or historical treatment with 3tc or ftc. 5. willing to change antiretroviral treatment due to intolerance or interest in simplification. 6. undetectable viral load (\ 50cop/ml (≤500 copies/ml) is allowed before the three months prior to inclusion in the study, preceded and followed by an undetectable determination. 7. current level of cd4\> 350 cells/μl. 8. naïve to integrase inhibitors. 9. patient able to understand and give written informed consent. 10. for those included in group 1 (20 patients): no previous history of virological failure with art regimen that included 3tc or ftc or previous virological failure had a population genotype without m184v/i or k65r/e/n mutations. 11. for those included in group 2 (20 patients): previous history of virological failure with art regimen that included 3tc or ftc and historical genotype with m184v/i or k65r/e/n mutations. exclusion criteria: 1. detection of any of the following mutations in proviral dna in peripheral blood by conventional sequencing: m184v/i or k65r/e/n. 2. pregnant, lactating or child-bearing women who do not commit to using an adequate contraceptive method.
single-cell rna sequencing resolves the regulatory role of hbv on the hepatocellular carcinoma immune microenvironment

Conditions: HBV; Primary Liver Cancer

Summary: in summary, with the help of single-cell sequencing technology, this study aims to focus on elucidating the influence of hbv-induced hepatocellular carcinoma cell metabolic changes on microenvironment remodeling. with the help of hepatocellular carcinoma microenvironment changes, this study provide a more accurate diagnosis and treatment method for hbv-induced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * patients with primary liver cancer (hepatocellular carcinoma (hcc)), with evidence of histological or cytological diagnosis, or with hcc meeting conventional clinical diagnostic criteria. * both sexes, aged 18-80 years old * the results of hbvdna test were in line with the inclusion criteria * the patient had at least one measurable lesion according to the response evaluation criteria in solid tumors, version 1.1 (recist v1.1) * agreed to comply with the study protocol for treatment and follow-up, agreed to provide clinicopathological and follow-up data required by the study, and agreed to use the study data for subsequent research and product development exclusion criteria: * other malignant tumors; * patients with severe organic diseases do not meet the requirements of infectious liver cancer in this study; * suffering from mental illness cannot guarantee the compliance of this study; * previous recipients of any cell or organ transplantation; * received local regional liver therapy (including various ablations, percutaneous ethanol or acetic acid injections, high-intensity focused ultrasound, transarterial embolization, chemotherapy, or chemoembolization plus embolization) within 14 days prior to study treatment initiation.
cardiac resynchronization therapy in adult congenital heart disease with systemic right ventricle: right-crt

Conditions: Congenital Heart Disease; Systemic Right Ventricle; Congenitally Corrected Transposition of the Great Arteries; Transposition of Great Vessels; Heart Failure Congenital

Summary: the main objective of right-crt is to assess the impact/efficacy of crt on functional capacity in achd patients with srv.

this study will be the first to bring evidence on crt efficacy in achd patients with heart failure and srv. if results are positives, crt may improve functional capacities and quality of life of patients and will become an option of choice in this population. if results are negatives, futile crt implantation may be avoided in this population in particular considering potential adverse effects and crt-related complications. double blind randomized cross-over trial. 40 patients will be enroled. their follow-up will be 6 months.

Eligibility criteria:
inclusion criteria: * systemic right ventricle (srv), * crt-p or crt-d device implanted for at least 1 month, * age ≥18 years old, * one of the two following crt indications: * nyha ii-iv, right ventricular ejection fraction ≤ 35% and spontaneous qrs duration ≥ 150 ms or * nyhai-iv, atrioventricular conduction disorders with ventricular pacing \> 40% (regardless right ventricular ejection fraction). * affiliation to a french social security system (beneficiary or legal) * informed and signed consent exclusion criteria: * pregnancy or breastfeeding * women of childbearing potential who do not have a negative pregnancy test and do not use one of the following methods of birth control: hormonal contraception or intrauterine device or bilateral tubal occlusion * patient benefiting from a measure of legal protection (guardianship, curatorship, under judicial safeguard, activated future protection mandate and family authorization), * cardiac surgery during the last 3 months or planned during the next 6 months, * percutaneous structural cardiac intervention planned during the next 6 months, * persistent atrial arrhythmia with catheter ablation planned during the next 6 months, * acute congestive heart failure, * dysfunction of at least one crt device lead that compromise biventricular pacing, * patient on ame * current participation in another interventional clinical study or being in the exclusion period at the end of a previous study.

Keywords: cardiac resynchronization therapy congenital heart disease systemic right ventricle heart failure
effect of preoperative supplementation in insulin resistance

Conditions: Liver Disease

Summary: to elucidate the effect of preoperative supplementation of carbohydrate and branched-chain amino acids on postoperative insulin resistance in patients undergoing hepatic resection, we set a randomized trial.

twenty-six patients with hepatectomy due to a live tumor were prospectively randomized to receive a preoperative supplementation with carbohydrate and branched-chain amino acids-enriched nutrient or not.

Eligibility criteria:
inclusion criteria: * the present study employed 26 patients, who underwent elective liver resection for hepatocellular carcinoma or adenocarcinoma. exclusion criteria: * body weight loss greater than 10 per cent during 6 months prior to the surgery * distant metastasis * or seriously impaired function of vital organs due to respiratory, renal or heart disease

Keywords: aen